CDC will withdraw request for Emergency Use Authorization Real-Time RT-PCR Diagnostic Panel
SAN LUIS OBISPO COUNTY — After introducing the “California Roars Back” plan, a part of the $75 billion budget surplus announced back in May, followed by hosting several “Vax for the Win” campaigns throughout June and July that offered prizes, trips, and cash winnings of $1.5 million per person for a total of $15 million. Along with a massive push for Californians to return to living life, Governor Gavin Newsom changed his tune on Tuesday and stated that now “We’re experiencing a pandemic of the unvaccinated.”
Newsom’s statement followed a press conference held at Kaiser Permanente Hospital in Oakland on Tuesday, Jul. 27. During the conference, it was announced that the State of California would require all state workers, workers in health care, and high-risk congregate settings to either show proof of full vaccination or be tested at least once per week (twice as a standard according to Newsom). In addition, Newsom encouraged all local government and other employers to adopt a similar protocol.
“We are now dealing with a pandemic of the unvaccinated, and it’s going to take renewed efforts to protect Californians from the dangerous Delta variant,” Newsom said. “As the state’s largest employer, we are leading by example and requiring all state and health care workers to show proof of vaccination or be tested regularly, and we are encouraging local governments and businesses to do the same. Vaccines are safe— they protect our family, those who truly can’t get vaccinated, our children, and our economy. Vaccines are the way we end this pandemic.”
As stated, unvaccinated workers will be subject to at least one weekly COVID-19 test and will be required to wear appropriate PPE. This requirement also applies to high-risk congregate settings like adult and senior residential facilities, homeless shelters, and jails.
The new policy for state workers will affect Aug. 2, and testing will be phased over the next few weeks. The new policy for health care workers and congregate facilities will take effect on Aug. 9, and health care facilities will have until Aug. 23 to come into full compliance.
On Jun. 10, the U.S. Food and Drug Administration (FDA) warned the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use. The FDA explained they have significant concerns that the performance of the test has not been adequately established, presenting a risk to health.
In addition, labeling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during the clinical studies of the tests. Finally, the test has not been authorized, cleared, or approved by the FDA for commercial distribution or use in the United States, as required by law. The FDA has identified this recall as a Class I recall, which is the most serious type of recall.
Then on Jul. 21, the Centers for Disease Control (CDC) announced that after Dec. 31 of this year, the CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The assay was first introduced in February 2020 for the detection of SARS-CoV-2 only.
According to the CDC, the PCR test used solely in San Luis Obispo County and nationally is inaccurate and could potentially risk false results. Therefore, they encourage laboratories to consider adopting a multiplexed method that can facilitate the detection and differentiation of SARS-CoV-2 and influenza viruses.
In May, after several reports were released regarding the inaccuracy of the PCR test, we asked the San Luis Obispo County Department of Public Health about the COVID testing and being able to tell the difference between COVID and influenza. Their response was, “In its own testing efforts at the Public Health Lab and those being conducted at our community testing locations, the County of SLO continues to utilize PCR testing now, at the same thresholds we have used throughout the pandemic…SLO County has identified PCR testing as a best practice and has therefore stayed with that method. This is also the method used for all confirmed positive cases logged in CalRedie, the state’s communicable disease reporting system. The County has also continued to test for influenza throughout the pandemic. However, we have seen very little influenza in comparison to COVID this flu season.”
Along with the CDC’s information, it was also confirmed that the current testing for COVID-19 can not detect different strains such as the Delta variant.
It has been reported that the COVID Delta Variant is what is causing the new outbreaks and hospitalizations to spike even though studies show that it is known to be more transmissible however not deadly.
San Luis Obispo County Public Health announced that they will host a media briefing on Thursday, Jul. 29 at 12:15 p.m. to update the public on the status of COVID-19 in the County and discuss the importance of getting vaccinated.
On Tuesday, afternoon SLO County reported that a resident in their seventies passed away due to COVID-19, and 253 new cases of COVID-19 have been confirmed in San Luis Obispo County in the past week.
It has not been confirmed if the resident had been vaccinated.
With this death, it was reported that 265 SLO County residents have died due to COVID-19. Five residents are currently hospitalized, including one in the ICU.
The County stated that five additional cases of the Delta variant have been identified over the past week and reported that only a small percent of COVID-19 cases are sequenced to determine their strain. Officials say the actual number of Delta variant is higher.
How the County is testing for the various strains of COVID has yet to be confirmed.
Also, on Thursday, the County Veterans Services Office will host a veteran outreach and vaccination event in Paso Robles. The event will provide veterans and their family members with community resources and information about potential Veterans Administration (VA) benefits.
A San Luis Obispo County Public Health mobile vaccination clinic will also be on-site, offering vaccinations to all members of the community.
The Paso Robles American Legion Post #50 will BBQ for the event, and all veterans who receive a vaccination on the day of the event will be given a free lunch. Lunch is available for purchase for those not receiving the vaccine.
To continue the vaccine give-a-ways, all attendees who get vaccinated at the event will receive a $25 gift card. In addition, Veterans will also receive a second $50 gift card to Grocery Outlet, compliments of SLO Veteran Services Collaborative.
The event will be held on Thursday, Jul. 29, from 11 a.m. to 2 p.m., at the Paso Robles Veterans Memorial Building located at 240 Scott St., in Paso Robles.
Currently, the three COVID-19 vaccinations in the U.S. are presented as safe and effective and still under emergency orders from the FDA.
The CDC states that the COVID-19 vaccinations will help protect from getting COVID-19, however as the current studies continue, reports show vaccinated individuals can still contract the virus.
Currently, the FDA has granted emergency use of three COVID-19 vaccines.
On Dec. 11, 2020, Pfizer-BioNTech became the first COVID-19 vaccine to receive a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) after the company reported positive clinical trial data included news that the vaccine was up to 95 percent effective at preventing symptomatic disease.
In June, the FDA announced it will place a warning on the Pfizer-BioNTech mRNA vaccines regarding a “likely association” between the Pfizer and Moderna vaccines and reported cases of heart inflammation in young adults.
This inflammation may occur in the heart muscle (myocarditis) or in the outer lining of the heart (pericarditis) and is considered important but uncommon—arising in about 12.6 cases per million-second doses administered.
The inflammation, in most cases, gets better on its own without medical intervention.
Current Status: Emergency use in the U.S.; authorized for use in the European Union (under the name Comirnaty).
The Moderna’s vaccine was the second one authorized for emergency use in the U.S.—it received FDA EUA on Dec. 18, 2020, about a week after the Pfizer vaccine. Moderna is also an mRNA vaccine, using the same technology as the Pfizer-BioNTech one and with a similarly high efficacy at preventing symptomatic disease.
As with Pfizer, the FDA announced in June it will place a warning label on the mRNA vaccines regarding a “likely association” between the Pfizer and Moderna vaccines and reported cases of heart inflammation in young adults.
This inflammation may occur in the heart muscle (myocarditis) or in the outer lining of the heart (pericarditis) and is considered important but uncommon—arising in about 12.6 cases per million-second doses administered. The inflammation, in most cases, gets better on its own without medical intervention.
Current Status: Emergency use in the U.S.; authorized for use in the European Union.
On Feb. 27, the FDA granted emergency use approval for a different type of vaccine, called a carrier, or virus vector, vaccine manufactured by Johnson & Johnson.
An analysis released by the FDA in late February showed that the vaccine might reduce the spread of the virus by vaccinated people.
The FDA has attached two warnings to the Johnson & Johnson vaccine. In July, it attached a warning after rare cases of the neurological disorder Guillain-Barré syndrome were reported in a small number of vaccination recipients. Most of the cases occurred within 42 days after vaccination.
In April, the FDA added a warning label after ending a pause on the vaccine it had recommended “out of an abundance of caution” over an uncommon but potentially serious blood clotting disorder occurred in a small number of recipients.
Current Status: Emergency use in the U.S.; authorized for use in the European Union (under the name Janssen).
For more information on vaccinations, visit fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines or speak to a medical physician.